'Covaxin for children may get DGCI nod before trial period'

8/22/2021
The Central government and the Drugs Controller General of India (DCGI) may give approval to the Covaxin vaccines for children soon for emergency use, sources said.

The administration of two doses of vaccination has been completed among children and blood samples have been sent for the third time to check the effectiveness in terms of producing antibodies among children, sources told IANS.

A total of 90 children were subjected to Covaxin trials in Karnataka.

However, the trial will take 210 days to complete. As it will take another 5 to 6 months from now, they can't wait till then in the current circumstances to release the vaccination for children, sources underlined.

"Final report will come on 210th day. The government and DGCI can take calls any day after 56th day of the trial Emergency use. However, the study period will be there for 210 days. Before also, while releasing Covid vaccines for adults the government of India and DCGI did not wait till the completion of 210 days. Vaccines were released earlier," sources said.

Cheluvamba Hospital in Mysuru attached to Mysore Medical College and Research Institute (MMCRI) entrusted with the conducting of Covaxin's Clinical trials on children has sent third blood samples of children to designated laboratories.

The DGCI might take a call for the release of Covid vaccines for the children after ensuring efficacy of vaccines through antibody titre tests, reliable sources in the health department told IANS.

The Mysuru Cheluvamba hospital is one among the five medical institutes identified in the country, which had got the institutional ethics committee approvals for Covaxin's clinical trials on children. The trials are being done in the monitoring of principal investigator and Associate Professor, department of Paediatrics Dr. Pradeep N.

The Covid vaccination trail for children comprises administration of two vaccinations between 0 and 28th day along with blood sampling. On 56th day, there will not be vaccination but blood samples will be collected. There will be another blood sampling on 118th and also on 210th day of the trail.

DGCI will give approvals in a phased manner first starting with children aged 12 years and above in the first phase. The approvals will be given for release of vaccines for 6 to 12 years of children and later for children aged between 2 to 6 years.

"Everyone is safe during the course of the trial except for around 10-12 children experiencing mild fever and pain on the day of vaccination and the following day. The symptoms disappeared after a day or two in them also. No vaccination related complications found," sources said.

Third wave will definitely be there, say health experts. "Paediatric population, if at all affected, will be with mild symptoms. So many are already infected and there is herd immunity among children. Until now we have not found any severe cases similar to adults," sources said.

"Most of the children will recover. Only fear is mutation of the virus and Paediatric ICUs are being readied to face the worst situations" a health expert said.

Zydus Cadila, a leading pharmaceutical company in India was recently authorized by DCGI for its needle-free ZyCoV-D Covid-19 vaccine for the children aged 12 years and above.

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